The FDA recommended Ocugen to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data".
The company said the tablet is the bioequivalent and therapeutically equivalent to the Theophylline extended-release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.
The study, published in the journal Cell Reports, screened thousands of existing drugs and drug-like molecules for their ability to inhibit the replication of the Covid-19-causing coronavirus, SARS-CoV-2.
As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market
Lupin said it does not believe that the observations will have an impact on disruption of supplies or the existing revenues from operations of this facility
The device targets adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD), the FDA said on Friday.